COREX team members were invited to a meeting of the Association of Clinical Trials Organizations (ACTO) Logistics Committee that was held in August. During a lively debate, a vital for the pharmaceutical industry initiation of new medicinal products’ labeling protocols and procedures in the Russian Federation was addressed.
In the course of the meeting several questions about the turnover of drugs and their withdrawal from circulation were discussed; another important matter that sparked an exchange of opinions had to do with the amount of responsibility that would fall on organizations that manage these activities. COREX’ quality director, Vitaly Shakhnazarov, spoke about our company’s approach to handling of drug labeling. It is worth mentioning that the proposed solutions have been designed to address the changes in labeling in a cost-conscious manner.
The panel had concluded that at present time some of the issues with the upcoming changes in drug labeling reform have more questions than answers and that an ongoing dialogue with the regulatory bodies to address perceived limitations is paramount.
The pharmaceutical industry has faced numerous challenges since the beginning of 2021 including the rush to supply COVID-19 vaccines. The start of the year also saw the departure of the UK from the EU and theEuropean Medicines Agency (EMA). The Medicines and Healthcare Products Regulatory Agency (MHRA) is now fully in charge of all regulatory matters, oversight of clinical research and approval of medicines.
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